Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.
研究概览
简要总结
Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.
详细描述
Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics.
The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release.
In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18- 60 years
- •ASA physical status I
- •Undergoing septoplasty
排除标准
- •Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
- •History of renal or hepatic insufficiency
- •Endocrinal Diseases
研究组 & 干预措施
group Bupivacaine
Group B; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) as preincisional local infiltration of the nasal mucosa of the nasal septum ,injected once before surgical intervention
干预措施: Bupivacaine (Drug)
group Bupivacaine +Dexmedetomidine
group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.
干预措施: Dexmedetomidine (Drug)
group Bupivacaine +Dexmedetomidine
group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.
时间窗: 3 hours
the number of patients that will need rescue drugs: propranolol 1mg will be given then after 15 minutes (with no improvement of the surgical field) nitroglycerin (NTG) infusion will be added in a titrated manner 0.1-0.5 μg/kg/min gradually till the target MAP (±60 mmHg) is reached.
次要结局
未报告次要终点
研究者
Marwa Zayed
Lecturer of anesthesia
Cairo University